Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Cardiovascular Research Society, Greece

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: Remote Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01158716

4.7.7.2010

Details and patient eligibility

About

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. The investigators hypothesized that a single remote ischemic preconditioning cycle would reduce peri-procedural troponin release.

Full description

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases, which is a sensitive and specific marker of myocyte necrosis. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events and a worst prognosis, especially in those patients with the most marked elevation in troponin concentration.

Recently, 3 cycles of 5-minute ischemia followed by 5-minute reperfusion of the upper extremities were shown to reduce troponin release in elective PCI. However, this ischemic preconditioning (IPC) protocol requires 30 minutes and is of limited use in the context of PCI at the time of initial cardiac catheterization (ad hoc coronary intervention).

Since experimental evidence suggests that IPC is a graded than an "all-or-nothing" phenomenon, and even a short, single IPC cycle may have protective effects in the myocardium, the investigators hypothesized that patients undergoing ad hoc coronary intervention would have reduced peri-procedural troponin release if subjected to a single, remote IPC cycle, between diagnostic catheterization and coronary intervention.

Enrollment: 94 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a significant stenosis as documented in coronary angiography eligible for PCI
• Patients ≥ 18 of age and able to give informed consent

Exclusion criteria

• Severe comorbidity (estimated life expectancy <6 months)
• Use of nicorandil or glibenclamide
• Elevated baseline cTnI before PCI
• Renal disease as documented by serum creatinine before PCI
• LVEF<35%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Remote Ischemic Preconditioning

Active Comparator group

Treatment:

Other: Remote Ischemic Preconditioning

Control

No Intervention group